Medical Device Exporters Can Now Get RCMCs From EEPC India
DGFT has noted that presently Export Promotion Council (EPC) for Medical Devices is not yet fully operational and cannot issue RCMCs. Therefore, it has temporarily allowed RCMCs for medical devices to be issued by the Engineering Export Promotion Council of India (EEPC India) or any other relevant EPC for medical devices. This measure will operate until the designated EPC for medical devices becomes fully functional.
Medical Device Testing to Follow Stricter Standards in India
The Ministry of Health and Family Welfare (MoHFW) is implementing stricter regulations for testing medical devices (MDs) and in-vitro diagnostics (IVDs) in India. This new directive emphasizes the importance of prioritizing BIS standards for testing whenever they are available.
Grace Period Granted for Class C & D Medical Device Licensing
CDSCO has decided that existing importers and manufacturers of Class C & D medical devices who submitted license applications to the Central Licensing Authority (CLA) by September 30, 2023, can continue their operations till August 16, 2024.
Medical Device License Holders Urged to Report Adverse Events On MvPI Platform
All medical device license holders are urged to strengthen their post-market surveillance systems and report adverse events promptly through appropriate channels, including the MvPI platform. License holders must have robust systems for identifying, documenting, and reporting adverse events associated with their devices.
CDSCO Issues Reminder For Payment Of Medical Device License Renewal Fees
The circular states that licenses for manufacturing or importing medical devices, and registration certificates for quality management system (QMS) audits and medical device testing labs, are issued indefinitely however, all stakeholders should ensure timely payment of the necessary fees to the designated government account before the deadline to maintain product market continuity.
Revision In Ceiling Prices Of Coronary Stents
The new ceiling prices are Rs. 10,509.79 per unit for Bare Metal Stents and Rs. 38,267.18 per unit for Drug Eluting Stents (DES). These prices are exclusive of Goods and Services Tax (GST). Manufacturers can revise their existing MRP (Maximum Retail Price) based on the new ceiling price and WPI increase.
India Strengthens International Cooperation in Medical Product Regulation
The Union Cabinet has been apprised of Memorandums of Intent (MoIs) and Understanding (MoUs) signed between the Central Drugs Standard Control Organization (CDSCO) and regulatory bodies from the Netherlands, the Dominican Republic and the Republic of Ecuador. These agreements focus on cooperation in the field of Medical Products Regulation.
CDSCO Launches National Single Window System Portal
This portal has been designed to build a system that functions as a one-stop shop for all the approvals required by the investor and facilitates ease of doing business. The NSWS Portal for CDSCO will be independent of the SUGAM Portal or the cdscomdonline portal.
Drug Alert List for November 2023
A total of 1197 samples were tested by the CDSCO. Based on the samples tested, CDSCO has found a total of 64 drugs, medical devices and cosmetics that are identified as being deficient.
CDSCO classifies In-Vitro Diagnostic Medical Devices under Medical Device Rules, 2017
This classification has been undertaken on the basis of intended use, risk associated with the device and other parameters. CDSCO has updated its List of In-Vitro Diagnostic Medical Devices (IVD Analyzers) and List of In-Vitro Diagnostic Medical Devices (IVD Instruments). It has also added List of In-Vitro Diagnostic Medical Devices (IVD- Specimen receptacle) and List of In-Vitro Diagnostic Medical Devices under provisions of sub-rule (2) rule 4 of the Medical Devices Rules, 2017.
